EA-97-207 - Conam Inspection, Inc.

This refers to the letter dated July 7, 1997 from Clifton A. Lake, attorney
for Conam Inspection, Inc., in response to the NRC Notice of Violation
and Proposed Imposition of Civil Penalty (Notice) sent to you on June
9, 1997. Our letter and Notice described three violations (Violations
I.A, I.B, and I.C) which were classified in the aggregate as a Severity
Level II problem.

A civil penalty of $16,000 was proposed for the violations to emphasize
the importance of compliance with NRC requirements, and the need for prompt
identification and comprehensive correction of violations. In addition,
two other violations (Violations II.A and II.B) were classified at Severity
Level IV for which no civil penalty was assessed.

In its response to the Notice, Conam admitted Violations I.A and II.B;
denied Violations I.B, I.C, and II.A; and requested remission or full
mitigation of the civil penalty.

After consideration of Conam's response, we have concluded, for the reasons
given in the Appendices attached to the enclosed Order Imposing Civil
Monetary Penalty, the following: (a) Violation II.A is hereby withdrawn;
and (b) Conam did not provide an adequate basis for withdrawing Violations
I.B and I.C, for mitigating the severity level of Violations I.A, I.B,
and I.C in the aggregate, or for mitigating the civil penalty associated
with Violations I.A, I.B, and I.C. Accordingly, we hereby serve the enclosed
Order on Conam Inspection, Inc., imposing a civil monetary penalty in
the amount of $16,000. As provided in Section IV of the enclosed Order,
payment should be made within 30 days of the date of this Order, by check,
draft, money order, or electronic transfer, payable to the Treasurer of
the United States and mailed to James Lieberman, Director, Office of Enforcement,
U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville
Pike, Rockville, MD 20852-2738. We will review the effectiveness of your
corrective actions during a subsequent inspection.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy
of this letter and the enclosures will be placed in the NRC's Public Document
Room.

Conam Inspection, Inc. (Conam or Licensee) is the holder of Byproduct
Materials License No. 12-16559-01 issued by the Nuclear Regulatory Commission
(NRC or Commission) on January 2, 1990. The license authorizes the Licensee
to possess and use certain byproduct materials in accordance with the
conditions specified therein at the Licensee's facilities in Columbus,
Ohio; Gary, Indiana; Reading, Pennsylvania; Gallipolis, Ohio; and at temporary
job sites anywhere in the United States where the NRC maintains jurisdiction
for regulating the use of licensed material.

II

An inspection and investigation of the Licensee's activities were conducted
between March 28, 1996 and November 12, 1996. The results of the inspection
and investigation indicated that the Licensee had not conducted its activities
in full compliance with NRC requirements. A written Notice of Violation
and Proposed Imposition of Civil Penalty (Notice) was served upon the
Licensee by letter dated June 9, 1997. The Notice states the nature of
the violations, the provisions of the NRC's requirements that the Licensee
had violated, and the amount of the civil penalty proposed for three of
the violations in the aggregate (Violations I.A, I.B, and I.C).

The Licensee responded to the Notice in a letter dated July 7, 1997.
In its response, the Licensee denied Violations I.B and I.C, and requested
remission or full mitigation of the civil penalty.

III

After consideration of the Licensee's response and arguments for mitigation
contained therein, the NRC staff has determined, as set forth in the Appendix
to this Order, that the Licensee did not provide an adequate basis for
withdrawing Violations I.B and I.C, or mitigating the severity level of
Violations I.A, I.B, and I.C in the aggregate, or mitigating the civil
penalty associated with Violations I.A, I.B, and I.C. Therefore, a civil
penalty in the amount of $16,000 should be imposed.

IV

In view of the foregoing and pursuant to Section 234 of the Atomic Energy
Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, IT IS
HEREBY ORDERED THAT:

The Licensee pay a civil penalty in the amount of $16,000 within
30 days of the date of this Order, by check, draft, money order, or electronic
transfer, payable to the Treasurer of the United States and mailed to
James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD
20852-2738.

V

The Licensee may request a hearing within 30 days of the date of this
Order. Where good cause is shown, consideration will be given to extending
the time to request a hearing. A request for extension of time must be
made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission Washington, D.C. 20555, and include a statement of good cause
for the extension. A request for a hearing should be clearly marked as
a "Request for an Enforcement Hearing" and shall be addressed to the Director,
Office of Enforcement, U.S. Nuclear Regulatory Commission Washington,
D.C. 20555, with a copy to the Commission's Document Control Desk, Washington,
D.C. 20555. Copies also shall be sent to the Assistant General Counsel
for Hearings and Enforcement at the same address and to the Regional Administrator,
NRC Region III, 801 Warrenville Road, Lisle, IL 60532.

If a hearing is requested, the Commission will issue an Order designating
the time and place of the hearing. If the Licensee fails to request a
hearing within 30 days of the date of this Order (or if written approval
of an extension of time in which to request a hearing has not been granted),
the provisions of this Order shall be effective without further proceedings.
If payment has not been made by that time, the matter may be referred
to the Attorney General for collection.

In the event the Licensee requests a hearing as provided above, the issues
to be considered at such hearing shall be:

(a) whether the Licensee was in violation of the Commission's
requirements as set forth in Violations I.B and I.C of the Notice referenced
in Section II above, and

(b) whether, on the basis of such violations and the additional violations
set forth in the Notice of Violation that the Licensee admitted, this
Order should be sustained.

FOR THE NUCLEAR REGULATORY COMMISSION
James Lieberman, Director
Office of Enforcement

Dated at Rockville, Maryland
this 5th day of November 1997

APPENDIX A

EVALUATIONS AND CONCLUSION

On June 9, 1997, the NRC issued to Conam Inspection, Inc., (Licensee
or Conam) a Notice of Violation and Proposed Imposition of Civil Penalty
(Notice) in the amount of $16,000 for violations identified during an
NRC inspection and investigation conducted from March 28 through November
12, 1996. The Licensee responded to the Notice by letter dated July 7,
1997. With regard to the violations assessed a civil penalty, the Licensee
admitted Violation I.A; denied Violations I.B and I.C; and requested remission
or full mitigation of the civil penalty. The NRC's evaluations and conclusion
regarding the Licensee's requests are as follows:

Restatement of Violation I.B

I.B 10 CFR 34.43(b) requires, in part, a licensee to ensure that a survey
with a calibrated and operable radiation survey instrument is made after
each radiographic exposure to determine that the sealed source has been
returned to its shielded position. The survey must include the entire
circumference of the radiographic exposure device and any source guide
tube.

Contrary to the above, on February 27, 1996, at Eli Lilly, Indianapolis,
IN, a Licensee radiographer did not perform an adequate survey after each
radiographic exposure to determine that the sealed source had been returned
to its shielded position, in that the survey did not include the entire
circumference of the radiographic exposure device and the source guide
tube.

Summary of Licensee's Response to Violation I.B

The Licensee, in its response, denies Violation I.B and states that on
February 28, 1996, the day following the incident, the radiographer expressly
stated to the Licensee's Radiation Safety Officer (RSO) that he had performed
a full 360-degree circumferential survey of the radiographic exposure
device.

NRC Evaluation of Licensee's Response to Violation I.B

The specific issue addressed in Violation I.B is whether the radiographer
performed the required survey to determine that the source had completely
been withdrawn into the radiographic exposure device. This requires, among
other things, that the radiographer be aware of the results of the survey,
especially the dose rate measured at the exit port (front) of the radiographic
exposure device. As noted on page 7 of the Licensee's reply to the Notice,
the Licensee states (regarding the radiographer's survey) that: "He then
failed to properly read his survey meter when he performed a radiation
survey in a 360-degree motion around the camera." The fact that the radiographer
improperly read the survey meter means that he failed to properly determine:
(1) whether the source had been completely withdrawn into the radiographic
exposure device; and (2) the radiological conditions and potential hazards
incident to use of radioactive material.

In addition, during the investigation conducted by the NRC's Office of
Investigations, the radiographer stated that he surveyed the radiographic
exposure device, but only on the sides. He also stated to the investigator
that because of the position of the radiographic exposure device, he did
not survey the front part. This conflicts with the information provided
by the radiographer to the Licensee's RSO, but appears to be more in line
with the facts of the case given the elevated exposure result to the radiographer's
film badge.

In either case, whether the radiographer improperly read the survey meter
or whether the radiographer failed to survey the front part, the NRC concludes
that Violation I.B occurred as stated in the Notice.

Restatement of Violation I.C

I.C 10 CFR 20.1201(a)(1)(i) requires, with exceptions not applicable
here, that a licensee control the occupational dose to individual adults
to an annual dose limit of 5 rems total effective dose equivalent.

Contrary to the above, the Licensee did not limit the annual occupational
dose to an adult radiographer to 5 rems, total effective dose equivalent.
Specifically, the individual received a radiation dose of a minimum of
6 rems, total effective dose equivalent, during an event on February 27,
1996.

Summary of Licensee's Response to Violation I.C

The Licensee, in its response, denies Violation I.C, states that the
NRC's methodology in determining the total effective dose equivalent is
flawed, and does not agree with the intent of the regulations. The Licensee
contends that using conventional dose assessment models, consensus industry
standards, and the NRC's own definitions, the maximum likely Total Effective
Dose Equivalent (TEDE) incurred by the radiographer during the event was
2.9 rems, based upon the radiographer's
description
of time and
motion.

As a basis for its argument, the Licensee asserts that while the Licensee's
consultant calculated a dose to the right thigh of 9.369 rems, this dose
does not constitute the TEDE. The Licensee states that the dose limits
are based on the 1976 [1977] recommendations of the International Commission
on Radiological Protection (ICRP), which states that there is a predictable
relationship between irradiation of the whole body and biological effects.
The Licensee argues that the dose to the radiographer's thigh is not an
appropriate predictor of biological effects, and thus should not be compared
to the primary dose limit in 10 CFR 20.1201.

The Licensee asserts that the ICRP recommendations should take precedence
in determining how the TEDE is computed. As such, in calculating the TEDE,
the Licensee uses weighting factors for each tissue area which are derived
from ICRP Publication 26. The Licensee believes this is an acceptable
approach because the Statements of Consideration for the issuance of the
revised 10 CFR Part 20 included, as reasons for the revision, the need
to incorporate updated scientific information, to reflect changes in the
basic philosophy of radiation protection, and to put into practice recommendations
from ICRP 26 and subsequent ICRP publications. The Licensee asserts that
sections 10 CFR 20.1003, which defines the TEDE, and 10 CFR 20.1201(a),
which specifies exposure limits, conform with ICRP 26 recommendations.

The Licensee maintains that the NRC's guidance on interpretation of 10
CFR 20.1201(c) permits use of external dose weighting factors. However,
the Licensee argues that the language in 10 CFR 20.1201(c): (1) conflicts
with the definition of deep-dose equivalent provided in 10 CFR 20.1003;
(2) is inconsistent with the ICRP recommendations; and (3) deviates from
the fundamental principles underlying the dose limits in 10 CFR Part 20.

The Licensee does note that the specific use of weighting factors other
than 1.0 for all organs was not approved by 10 CFR Part 20; rather, 10
CFR 20.1003 states that "[f]or the purpose of weighting the external whole-body
dose (for adding it to the internal dose), a single weighting factor,
Wt = 1.0, has been specified. The use of other weighting factors for external
exposures will be approved on a case-by-case basis until such time as
specific guidance is issued." The Licensee notes that the NRC has not
yet issued specific guidance in interpreting this issue; however, since
the American National Standards Institute (ANSI) has issued N13.41, "Criteria
for Performing Multiple Dosimetry," the Licensee believes that it should
be able to use this methodology in computing its TEDE value. This guidance
was utilized and the resulting TEDE was 2.9 rems.

The Licensee asserts that in light of the conflicting regulatory language
in 10 CFR Part 20 regarding non-uniform exposure of the whole body, and
the fact that 10 CFR 20.1003 allows weighting factors to be considered,
the dose determined for the radiographer using ANSI N13.41 protocol was
appropriate and consistent with the rationale underlying the occupational
dose limits.

NRC Evaluation of Licensee's Response to Violation I.C

The specific issue addressed in Violation I.C is whether the radiographer's
total effective dose equivalent
as defined in the regulations
exceeded
the regulatory limits. The Licensee's use of ICRP 26 and ANSI N13.41 (i.e.,
use of a compartmentalization methodology to sum the effective dose equivalents
for various areas of the whole body) was neither approved by the NRC nor
in accordance with NRC requirements, for the reasons described below.

1. NRC Basis for Violation I.C: As noted in the Notice,
10 CFR 20.1201(a)(1)(i) requires, in part, that a licensee control the
occupational dose to individual adults to an annual dose limit of 5 rems
total effective dose equivalent. In addition, 10 CFR 20.1201(c) requires,
in part, that the assigned deep-dose equivalent must be for the part of
the body receiving the highest exposure and that the deep-dose equivalent
may be assessed from surveys or other radiation measurements for the purpose
of demonstrating compliance with the occupational dose limits, if the
individual monitoring device was not in the region of highest potential
exposure. As defined in 10 CFR 20.1003, Whole body means: "for purposes
of external exposure, head, trunk (including male gonads), arms above
the elbow, or legs above the knee."1

Based on the findings in the NRC inspection report dated November
18, 1996, the NRC concluded, as described in the Notice, that the radiographer
received a TEDE of 6 rems. The conclusion was based on: (1) measurements
of time and distances as re-enacted by the radiographer and the Licensee's
film badge dose; and (2) the dose to the part of the body receiving
the highest exposure (i.e., upper left thigh), given that the individual
monitoring device was not in the region of highest potential exposure,
the dose field from the radiographic exposure device was non-uniform,
and the position of the radiographer and his film badge in relationship
to the radiographic exposure device.

2. The Licensee's Use of ICRP 26 and ANSI N13.41: The NRC agrees
that the dose limits in 10 CFR Part 20 are based on the ICRP 26 recommendations
and acknowledges that the radiographer's thigh may not be an appropriate
predictor of biological effects. However, the Licensee's use of ICRP
26 and the draft ANSI N13.41 for calculating the radiographer's whole-body
dose is inappropriate in this case.

While the ICRP 26 recommendations in principle permit the use of external
weighting factors, no specific recommendations were included concerning
the use of weighting factors for external dose because there are practical
problems with such use. The application of weighting factors also entails
calculation of organ doses instead of whole-body doses from external
radiation. One component of this calculation is the estimation of radiation
attenuation as a function of the depth in the body. Therefore, as noted
in the NRC's Statement of Consideration for 10 CFR Part 20 (56 FR 23369),
the Commission decided that "application of weighting factors for external
exposures will be evaluated on a case-by-case basis until more guidance
and additional weighting factors (such as for the head and the extremities)
are recommended ... The use of other weighting factors for external
exposure may be approved on a case-by-case basis upon request to
the NRC." (emphasis added). This means that, if a licensee proposes
to use other weighting factors for external use, the licensee needs
to develop the basis and technical justification for its request, submit
the request to the NRC, and await approval of its request before
using any modified weighting factors. To date, the Licensee has
not submitted to the Commission such a request for an exemption of 10
CFR 20.1201.

With regard to ANSI N13.41, this is a draft standard that has
been neither approved by ANSI, nor reviewed and approved by the Commission
for use by NRC licensees. Moreover, ANSI N13.41 is not applicable because
this case falls outside of the scope of that standard. This is evident
from the standard itself, which states, under Scope, page 9,
that "this standard contains criteria applicable to routine occupational
activities (emphasis added) for when and how to use multiple dosimeters
to monitor the body and extremity of individuals exposed to sources
of ionizing radiation." The next paragraph under this section goes on
to state, "Sudden or unexpected changes in the radiation environment
as might occur during accidents are beyond the scope of this standard"
(emphasis added).

The dose calculated by the consultant to the radiographer's right
thigh was 9.369 rems. As noted in the Licensee's response, the footnote
attached to 10 CFR 20.1003 specifies that a single weighting factor,
Wt=1.0, be used for external exposures. However, rather than using this
weighting factor, the Licensee applied the factors provided in ANSI
N13.41 (which are less than 1.0) to calculate exposures of portions
of the whole body to arrive at the overall dose determination. The Licensee's
use of weighting factors (on the basis that the NRC has not issued new
weighting factors) without prior NRC approval is contrary to NRC requirements.
Given the above, the Licensee's method for calculating the radiographer's
exposure is incorrect.

3. Arguments Concerning Deep-Dose Equivalent: 10 CFR 20.1201(c)
requires, in part, that the assigned deep-dose equivalent must be for
the part of the body receiving the highest exposure. 10 CFR 20.1003
defines deep-dose equivalent as the dose equivalent at a tissue depth
of 1 cm (1000 mg/cm2) [regardless of the part of the whole
body that is exposed]. Given that ICRP 26 did not include specific recommendations
concerning the use of weighting factors for external dose, and the fact
that there are practical problems in using weighting factors to assess
external exposure as noted above, the NRC disagrees with the Licensee's
argument that 10 CFR 20.1201(c) is inconsistent with the ICRP recommendations
and that 10 CFR 20.1201(c) deviates from the fundamental principles
underlying the dose limits in 10 CFR Part 20.

4. Use of the Consultant Results and Part 20 Weighting Factors:
The NRC bases its enforcement actions on its regulations as codified
in Title 10, Code of Federal Regulations. In this case, 10 CFR 20.1003
defines the weighting factor for the whole body as 1.0. As noted in
the Licensee's response, the NRC has not approved the use of other weighting
factors for external exposures nor has the NRC issued specific guidance
on the use of other weighting factors. The regulations do allow for
the use of a different methodology, but only after review and prior
approval by the NRC. In this case, such approval was not obtained by
the Licensee. Because the thigh (right or left) is an area of the body
meeting the definition for whole body, the appropriate weighting factor
per the regulations is 1.0. Therefore, if the Licensee chooses to use
the consultant's results in conjunction with the Part 20 weighting factors,
the radiographer's TEDE for the event would be:

The Licensee correctly notes that the limit for whole-body exposure
in 10 CFR 20.1201(a)(1)(i) is a TEDE of 5 rems. 10 CFR 20.1003 defines
the TEDE as the sum of the deep-dose equivalent (external exposure)
and committed effective dose equivalent (internal exposure). In this
case, the TEDE can be considered to be equal to the deep-dose equivalent,
because there was no internal exposure involved.

The circumstances surrounding the exposure, as described in the inspection
report and by the radiographer during the conduct of the NRC's investigation,
demonstrated that the radiographer's body was between the radiographic
exposure device and the radiographer's film badge. As noted in the radiographer's
and RSO's description of the Licensee's time-motion study, no props
were used - the event was discussed at a table with the radiographer
describing to the RSO what occurred. During this time-motion discussion,
it was not clear that the radiographer's film badge was at the point
nearest the source. It was clear that the beam from the exit port of
the radiographic exposure device would be very directional and non-uniform.
Later, on April 11, 1996, a re-enactment of the event by the radiographer
in the presence of the Licensee's RSO and NRC personnel was performed
and appropriate props were used. The radiographer was asked to demonstrate
his activities at the time the exposure occurred. This re-enactment
provided information that the Licensee had not obtained during its verbal
time-motion discussion, namely, that the radiographer's leg was significantly
closer to the source than was his film badge. For the sake of argument,
the NRC has chosen to utilize the Licensee's dose calculation based
on its verbal characterization, and the resulting dose obtained to the
right thigh. If the Licensee chooses to use the consultant's results
(which utilized variables from the NRC's re-enactment) in conjunction
with the Part 20 weighting factors, the radiographer's TEDE for the
event would be:

10 CFR 20.1201(c) states that "the assigned deep-dose equivalent and
shallow-dose equivalent must be for the part of the body receiving the
highest exposure. The deep-dose equivalent, eye dose equivalent and
shallow-dose equivalent may be assessed from surveys or other radiation
measurements for the purpose of demonstrating compliance with the occupational
dose limits, if the individual monitoring device was not in the region
of highest potential exposure, or the results of individual monitoring
are unavailable." In this case, the individual monitoring device was
not in the region of highest potential exposure, given the non-uniform
nature of the dose field from the radiographic exposure device and the
position of the radiographer and his film badge in relationship to the
radiographic exposure device. Therefore, per this requirement, the assigned
deep-dose equivalent must be for the right thigh (using the Licensee's
computation), as it is part of the whole body. This results in an assigned
deep-dose equivalent of 9.369 rems. As noted above, the TEDE consists
of the sum of the deep-dose equivalent and committed effective dose
equivalent. In this case, it is equal to the deep-dose equivalent, 9.369
rems, a value that is in excess of the limit specified in 10 CFR 20.1201(a)(1)(i).

Given the above, the NRC concludes that: (a) the Licensee has not provided
a basis to substantiate that the radiographer's TEDE was below 5 rems;
and (b) Violation I.C occurred as stated in the Notice.

Summary of Licensee's Request for Remission or Mitigation and Reconsideration
of Severity Level

The Licensee offered several arguments in support of its request for
remission or mitigation of the proposed penalty. Below is a summary listing
of the Licensee's arguments that are related to its request for remission
or mitigation, some of which have been consolidated. The NRC's evaluation
follows each argument.

1.
Licensee's Argument

The Licensee asserts that violations cited in Section I of the Notice
should not be considered willful, for the following reasons:

Based on the Licensee's discussion of the event on February 28, 1996,
between the RSO and the radiographer, the Licensee concluded that the
radiographer was negligent in failing to rotate the selector ring from
the "operate" to the "lock" position and failing to depress the plunger
mechanism of the radiographic exposure device.

This act was not the result of deficiencies in the Licensee's Radiation
Safety Program, nor did it follow other incidents of a similar nature.
As evidence for its argument, the Licensee notes that seven prior unannounced
NRC inspections had not identified any violations of applicable regulations.

The Licensee disputes the fact that it was a "typical" practice of
Conam radiographers to rely upon the automatic locking mechanism of
their radiographic exposure devices rather than locking them in the
manner required by the Licensee's radiation safety procedures.

The Licensee believes that "[b]ecause the NRC's conclusion that a
'willful' violation has occurred is influenced by its erroneous conclusion
that a violation of the occupational exposure limit occurred, its characterization
of the violation as 'willful' is flawed."

NRC Evaluation

In its Notice, the NRC did not conclude that the violations in Section
I were willful; rather, the NRC concluded that only Violation I.A was
willful. In this regard, Section IV.C of the NRC Enforcement Policy defines
willful violations to encompass not merely deliberate acts but acts of
careless disregard as well. As part of the NRC's evaluation of this event,
an investigation was conducted by the NRC's Office of Investigations (OI).
That investigation concluded that the Licensee's radiographer willfully
failed to follow the Licensee's procedures while operating the radiographic
exposure device. The radiographer, who was knowledgeable of the requirement
but failed to perform it due to being "lax," demonstrated careless disregard
for NRC requirements, a condition that clearly meets the NRC's definition
of a willful violation.

Given the results of the OI investigation, the problem with failing
to follow procedures was not isolated. As noted both in the November 18,
1996 inspection report and during the subsequent Predecisional Enforcement
Conference, the Licensee's policy for performing field audits did not
encompass multiple exposures or other situations where the potential existed
for a radiographer to fail to properly rotate the selector ring and depress
the plunger. A single radiographic shot was often used, where this act
would be performed prior to moving the radiographic exposure device. As
such, the Licensee was unaware of the problem until it manifested itself
in the exposure event that occurred on February 27, 1996, although a better
field auditing technique may have allowed the Licensee to identify the
problem prior to the February event. Therefore, the Licensee's arguments
(i.e., lack of deficiencies in its radiation safety program and the lack
of NRC findings during prior unannounced NRC inspections) do not alter
the NRC's conclusion concerning the willful act of the radiographer.

When questioned by the OI investigator, approximately 25% of the Licensee's
radiographers at the Gary, Indiana facility, including the radiographer
associated with the event, admitted that on or prior to February 28, 1996,
they failed on occasion to rotate the selector ring from the "operate"
to the "lock" position and failed to depress the plunger mechanism as
required by the Licensee's operating procedures. They stated to the investigator
that they had been "lax," but that they were knowledgeable of the requirement.
They also stated that after the memo was issued by the RSO discussing
the event and the need to follow procedures, they no longer violated this
requirement.

In determining whether the radiographer willfully failed to lock the
radiographic exposure device, the NRC based its conclusion on interviews
with the radiographer as noted above. The Licensee's belief that the NRC's
conclusion concerning willfulness was influenced by whether a violation
of the occupational exposure limit occurred is simply incorrect.

2.
Licensee's Argument

The Licensee asserts that the NRC improperly denied identification and
corrective action credit under the terms of the NRC Enforcement Policy,
Section VI.B.2.b and c, by ignoring essential facts. The Licensee asserts
that while the incident was identified through an event, this fact does
not preclude identification credit where the problem arose from a single
incident of negligence by a radiographer in violation of well-publicized
Conam safety procedures, where the Licensee's quarterly radiation safety
compliance audit program was demonstrably adequate, and where there were
no prior deficient occurrences to identify the problem.

In addition, the Licensee argues that its corrective actions were also
prompt and comprehensive and should result in credit. The Licensee believes
that the incident was promptly and comprehensively addressed and corrected
by the Licensee's RSO through his analysis of the film badge, his issuance
of a February 29, 1996, memorandum reminding all Conam radiographic personnel
of the proper procedure for operating radiographic exposure devices, his
withdrawal of the radiographer from further radiographic duties, and the
suspension of the radiographer without pay for one week.

The Licensee disagrees with the NRC's position, as described in the
Notice, that credit should not be given because the Licensee did not confirm
that each radiographer had received the February 29, 1996, memorandum
from the RSO, nor had the Licensee instituted any monitoring/auditing
program to evaluate the effectiveness of the memorandum. The Licensee
states that there is no evidence that the radiographers did not receive
the memorandum, and that there has been no repetition of the problem since
the February event's occurrence. The Licensee believes that the NRC's
dismissal of credit for identification and corrective action ignores the
fact that the February event was the only one of its kind against a record
of no violations whatsoever during seven prior NRC inspections, and no
that subsequent violations since the event have been identified by NRC
inspections.

NRC Evaluation

The NRC Enforcement Policy, Section VI.B.2.b, discusses the criteria
to be considered when deciding if a licensee should be given credit for
actions related to identification. These circumstances include: (i) whether
the problem requiring corrective action was NRC-identified, licensee-identified,
or revealed through an event; and (ii) for a problem revealed through
an event, the ease of discovery, the licensee's self-monitoring effort,
the degree of licensee initiative in identifying the problem requiring
corrective action, and whether prior opportunities existed to identify
the problem (Section VI.B.2.b(2)(ii) of the Enforcement Policy).

The NRC and the Licensee both agree that the problem requiring corrective
action was revealed through an event. Therefore, the criteria in Section
VI.B.2.b(2)(ii) of the Enforcement Policy are applicable in this case.
Regarding the ease of discovery, as well as the Licensee's self-monitoring
effort, the radiographer involved in the incident reported the problem
to the Licensee's RSO; and the problem was not identified through any
self-monitoring action of the Licensee's RSO or management, such as an
audit. Regarding the degree of licensee initiative in identifying the
problem requiring corrective action, the Licensee's initiative does not
deserve credit, as described below. Regarding the existence of prior opportunities
to identify the problem, as stated earlier, the OI investigation revealed
that approximately 25% of the Licensee's radiographers and assistant radiographers
at the Gary, Indiana facility admitted that on or prior to February 28,
1996, they on occasion failed to rotate the selector ring from the "operate"
to the "lock" position and failed to depress the plunger mechanism as
required by the Licensee's operating procedures. Thus, the problem with
failing to follow procedures was not isolated. The Licensee performs quarterly
field audits of its radiographers. As noted in the inspection report and
during the Predecisional Enforcement Conference, the Licensee's policy
for performing field audits did not encompass multiple exposures or other
situations where the potential existed for a radiographer to fail to properly
rotate the selector ring and depress the plunger. Therefore, numerous
prior opportunities existed to identify the problem, yet the problem was
not identified prior to the February 27, 1996 incident. Thus, credit for
identification is not warranted.

The NRC Enforcement Policy, Section VI.B.2.c, discusses the criteria
to be considered when deciding if a licensee should be given credit for
prompt and comprehensive corrective actions. These criteria include: (i)
the timeliness of the corrective action, (ii) the adequacy of the licensee's
root cause analysis for the violation, and (iii) the comprehensiveness
of the corrective action. As stated in the inspection report, the NRC
acknowledges the Licensee's prompt action in issuing a memorandum to all
radiation safety supervisory personnel advising all radiography staff
to complete a full and accurate survey of the radiographic exposure device,
collimator, guide tube, and connector after each exposure and to secure
the source assembly in accordance with the Licensee's procedures. However,
although the issuance of the memorandum was timely, it does not constitute
a comprehensive corrective action.

Specifically, after the Licensee received the vendor's report indicating
the radiographer's dose, the Licensee did not perform an exact time-motion
study at the scene of the event to determine the locations of the whole
body, film badge and radiographic exposure device exit port. Photographs
of the scene that were obtained later did not include the position of
the radiographer. In addition, the Licensee could not confirm that each
radiographer had received the memorandum, nor had the Licensee instituted
any monitoring/auditing program to evaluate the effectiveness of the memorandum.
The Licensee's argument that there is no evidence that the radiographers
did
not
receive the memorandum is not persuasive; a comprehensive
corrective action would ensure that each radiographer had received, reviewed,
and understood the memorandum, and would monitor the radiographers' understanding
of and compliance with the memorandum. Such comprehensive corrective actions
were not implemented by the Licensee.

Finally, the fact that no violations had been identified during seven
NRC inspections prior to the February 27, 1996 event, although commendable,
is not relevant as far as credit for corrective action is concerned. Further,
in accordance with Section VI.B.2.c of the NRC Enforcement Policy, the
adequacy of a licensee's corrective actions is judged at the time of the
enforcement conference, not on the basis of whether subsequent violations
following the event have been identified by the NRC. Given the above,
the NRC concludes that while the Licensee took some timely actions, on
balance, such actions did not address the root cause of the violations
and were not comprehensive. Thus, credit for prompt and comprehensive
corrective actions is not warranted.

3.
Licensee's Argument

The Licensee asserts that the NRC Enforcement Policy should find,
at
worst
, that the February 27,1996 incident involved two non-willful
Severity Level III violations which, with appropriate identification and
corrective action credit, do not justify any civil penalty. The Licensee
asserts that to aggregate the violations cited in Section I of the Notice
and assign a Severity Level II "problem" to this collection is not consistent
with the NRC's Enforcement Policy published in 60 FR 34381 (June 30, 1995).
The Licensee believes that the NRC's Notice compounds that error by determining
that the Severity Level II problem was willful, and on that basis justifying
a 100% escalation of the $8,000 Severity Level II base penalty.

NRC Evaluation

As described above, the NRC has determined that Violation I.A was willful,
that Violations I.A, I.B, and I.C occurred as described in the inspection
report, and that credit for identification and corrective action is not
warranted. The NRC Enforcement Policy, Section IV.A, states, in part,
that the purpose of aggregating violations is to focus the licensee's
attention on the fundamental underlying causes for which enforcement action
appears warranted and to reflect the fact that several violations with
a common cause may be more significant collectively than individually
and may, therefore, warrant a more substantial enforcement action. As
noted in the Notice, in consideration of the willfulness involved, the
relationship of these violations to a single incident, and the fact that
two safety barriers were breached, the violations are of very significant
regulatory concern. Therefore, consistent with Section IV.A of the Enforcement
Policy, the violations in Section I of the Notice were combined to reflect
that, collectively, they are more significant than individually and, therefore,
warrant a more substantial enforcement action.

As to the Licensee's argument concerning escalation of the $8,000 base
penalty, the NRC did not escalate the civil penalty on the basis of a
willful violation. The base amount for a Severity Level II problem is
$8,000. Credit was not warranted for the identification and corrective
action factors. Therefore, in accordance with the civil penalty assessment
process described in Section VI.b.2, the civil penalty for the Severity
Level II problem is twice the base amount (i.e., $16,000).

NRC Conclusion

The NRC concludes that the Licensee did not provide an adequate basis
for withdrawing Violations I.B and I.C, for mitigating the severity level
of Violations I.A, I.B, and I.C in the aggregate, or for mitigating the
civil penalty associated with Violations I.A, I.B, and I.C. Therefore,
the proposed civil penalty in the amount of $16,000 should be imposed
by order.

APPENDIX B

EVALUATION OF VIOLATIONS

NOT ASSESSED A CIVIL PENALTY

Of the violations not assessed a civil penalty, the Licensee admitted
violation II.B and denied Violation II.A.

Restatement of Violation II.A

II.A 10 CFR 20.2203(a)(2)(i) requires, in part, that a licensee submit
a written report within 30 days after learning of a dose in excess of
the occupational dose limits for adults as defined in 10 CFR 20.1201.

Contrary to the above, on April 11, 1996, the Licensee learned of an
event that caused an adult radiographer to receive a total effective dose
equivalent of more than 5 rems total effective dose equivalent and did
not submit a written report within 30 days as required.

Summary of Licensee's Response to Violation II.A

The Licensee, in its response, denies Violation II.A and states that,
because the radiographer was not exposed to a dose in excess of 5 rems,
total effective dose equivalent, no reporting obligation arose under applicable
regulations.

NRC Evaluation of Licensee's Response to Violation II.A

The specific issue raised by Violation II.A was whether the Licensee
was required to submit a report to the NRC after learning of a dose in
excess of the occupational dose limits for adults as defined in 10 CFR
20.1201. In this case, the Licensee's evaluation of the circumstances
did not appear to be adequate in that the Licensee did not complete an
exact time/motion study at the scene of the event to determine the locations
of the whole body, film badge, and radiography exposure device. As a result,
the Licensee did not conclude that an exposure in excess of the dose limits
occurred.
(2)

By letter dated June 23, 1997, the Licensee did submit the report required
by 10 CFR 20.2203(a)(2)(i), but solely on the basis that the NRC's letter
transmitting the Notice of Violation and Proposed Imposition of Civil
Penalty specifically stated that the Licensee was required to make such
a report. As noted above, the Licensee still contends that an exposure
in excess of regulatory limits did not occur based on the Licensee's unapproved
methodology it used to compute the TEDE.

Given that the Licensee did not learn that the radiographer's exposure
was in excess of regulatory limits, and that, after being informed by
the NRC of the radiographer's exposure, the Licensee submitted a report
per the requirements of 10 CFR 20.2203(a)(2)(i), the NRC concludes that
Violation II.A should be withdrawn.

NRC Conclusion

The NRC staff concludes that the Licensee provided an adequate basis
for withdrawing Violation II.A. Therefore, Violation II.A should be withdrawn.

1. The NRC's definition is based, in part, on the fact
that these portions of the whole body contain blood-forming organs.